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The Cochrane Database of Systematic... Mar 2017Premenstrual syndrome (PMS) is a psychological and somatic disorder of unknown aetiology, with symptoms typically including irritability, depression, mood swings,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Premenstrual syndrome (PMS) is a psychological and somatic disorder of unknown aetiology, with symptoms typically including irritability, depression, mood swings, bloating, breast tenderness and sleep disturbances. About 3% to 10% of women who experience these symptoms may also meet criteria for premenstrual dysphoric disorder (PMDD). PMS symptoms recur during the luteal phase of the menstrual cycle and reduce by the end of menstruation. PMS results from ovulation and may be due to ovarian steroid interactions relating to neurotransmitter dysfunction. Premenstrual disorders have a devastating effect on women, their families and their work.Several treatment options have been suggested for PMS, including pharmacological and surgical interventions. The treatments thought to be most effective tend to fall into one of two categories: suppressing ovulation or correcting a speculated neuroendocrine anomaly.Transdermal oestradiol by patch, gel or implant effectively stops ovulation and the cyclical hormonal changes which produce the cyclical symptoms. These preparations are normally used for hormone therapy and contain lower doses of oestrogen than found in oral contraceptive pills. A shortened seven-day course of a progestogen is required each month for endometrial protection but can reproduce premenstrual syndrome-type symptoms in these women.
OBJECTIVES
To determine the effectiveness and safety of non-contraceptive oestrogen-containing preparations in the management of PMS.
SEARCH METHODS
On 14 March 2016, we searched the following databases: the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register; Cochrane Central Register of Studies (CRSO); MEDLINE; Embase; PsycINFO; CINAHL; ClinicalTrials.gov; metaRegister of Controlled trials (mRCT); and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) Search Portal. In addition, we checked the reference lists of articles retrieved.
SELECTION CRITERIA
We included published and unpublished randomized placebo or active controlled trials on the efficacy of the use of non-contraceptive oestrogen-containing preparations in the management of premenstrual syndrome in women of reproductive age with PMS diagnosed by at least two prospective cycles without current psychiatric disorder.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies, assessed risk of bias, extracted data on premenstrual symptoms and adverse effects and entered data into Review Manager 5 software. Where possible, intention-to-treat or modified intention-to-treat analysis was used. Studies were pooled using a fixed-effect model, analysing cross-over trials as parallel trials. Standardised mean differences (SMDs) with 95% confidence intervals (CIs) were calculated for premenstrual symptom scores. Risk ratios (RRs) with 95% confidence intervals (CIs) were calculated for dichotomous outcomes. The overall quality of the evidence was assessed using the GRADE working group methods.
MAIN RESULTS
The search resulted in 524 potentially relevant articles. Five eligible randomized controlled trials (RCTs) were identified (305 women). Trials using oral tablets, transdermal patches and implants were identified. No trial used gels.One small cross-over trial (11 women, effective sample size 22 women considering cross-over trials) compared oral luteal-phase oestrogen versus placebo. Data were very low quality and unsuitable for analysis, but study authors reported that the intervention was ineffective and might aggravate the symptoms of PMS. They also reported that there were no adverse events.Three studies compared continuous oestrogen with progestogen versus placebo (with or without progestogen). These trials were of reasonable quality, although with a high risk of attrition bias and an unclear risk of bias due to potential carry-over effects in two cross-over trials. Continuous oestrogen had a small to moderate positive effect on global symptom scores (SMD -0.34, 95% CI -0.59 to -0.10, P = 0.005, 3 RCTs, 158 women, effective sample size 267 women, I² = 63%, very low quality evidence). The evidence was too imprecise to determine if the groups differed in withdrawal rates due to adverse effects (RR 0.64, 95% CI 0.26 to 1.58, P = 0.33, 3 RCTs, 196 women, effective sample size 284 women, I² = 0%, very low quality evidence). Similarly, the evidence was very imprecise in measures of specific adverse events, with large uncertainties around the true value of the relative risk. None of the studies reported on long-term risks such as endometrial cancer or breast cancer.One study compared patch dosage (100 vs 200 µg oestrogen, with progestogen in both arms) and had a high risk of performance bias, detection bias and attrition bias. The study did not find evidence that dosage affects global symptoms but there was much uncertainty around the effect estimate (SMD -1.55, 95% CI -8.88 to 5.78, P = 0.68, 1 RCT, 98 women, very low quality evidence). The evidence on rates of withdrawal for adverse events was too imprecise to draw any conclusions (RR 0.70, 95% CI 0.34 to 1.46, P = 0.34, 1 RCT, 107 women, low-quality evidence). However, it appeared that the 100 µg dose might be associated with a lower overall risk of adverse events attributed to oestrogen (RR 0.51, 95% Cl 0.26 to 0.99, P = 0.05, 1 RCT, 107 women, very low quality evidence) with a large uncertainty around the effect estimate.The overall quality of the evidence for all comparisons was very low, mainly due to risk of bias (specifically attrition), imprecision, and statistical and clinical heterogeneity.
AUTHORS' CONCLUSIONS
We found very low quality evidence to support the effectiveness of continuous oestrogen (transdermal patches or subcutaneous implants) plus progestogen, with a small to moderate effect size. We found very low quality evidence from a study based on 11 women to suggest that luteal-phase oral unopposed oestrogen is probably ineffective and possibly detrimental for controlling the symptoms of PMS. A comparison between 200 µg and 100 µg doses of continuous oestrogen was inconclusive with regard to effectiveness, but suggested that the lower dose was less likely to cause side effects. Uncertainty remains regarding safety, as the identified studies were too small to provide definite answers. Moreover, no included trial addressed adverse effects that might occur beyond the typical trial duration of 2-8 months. This suggests the choice of oestrogen dose and mode of administration could be based on an individual woman's preference and modified according to the effectiveness and tolerability of the chosen regimen.
Topics: Administration, Oral; Drug Implants; Drug Therapy, Combination; Estrogens; Female; Humans; Luteal Phase; Premenstrual Dysphoric Disorder; Premenstrual Syndrome; Progestins; Randomized Controlled Trials as Topic; Transdermal Patch
PubMed: 28257559
DOI: 10.1002/14651858.CD010503.pub2 -
BMC Women's Health Aug 2018Since the publication over 50 years ago of the alkaline hematin method for quantifying menstrual blood loss (MBL) many new approaches have been developed to assess MBL....
BACKGROUND
Since the publication over 50 years ago of the alkaline hematin method for quantifying menstrual blood loss (MBL) many new approaches have been developed to assess MBL. The aim of this systematic review is to determine for methods of measuring MBL: ability to distinguish between normal and heavy menstrual bleeding (HMB); practicalities and limitations in the research setting; and suitability for diagnosing HMB in routine clinical practice.
METHODS
Embase®™, MEDLINE®, and ClinicalTrials.gov were screened for studies on the development/validation of MBL assessment methods in women with self-perceived HMB, actual HMB or uterine fibroids, or patients undergoing treatment for HMB. Studies using simulated menstrual fluid and those that included women with normal MBL as controls were also eligible for inclusion. Extracted data included study population, results of validation, and advantages/disadvantages of the technique.
RESULTS
Seventy-one studies fulfilled the inclusion criteria. The sensitivity and/or specificity of diagnosing HMB were calculated in 16 studies of methods involving self-perception of MBL (11 pictorial), and in one analysis of the menstrual-fluid-loss (MFL) method; in 13 of these studies the comparator was the gold standard alkaline hematin technique. Sensitivity and specificity values by method were, respectively: MFL model, 89, 98%; pictorial blood loss assessment chart (PBAC), 58-99%, 7.5-89%; menstrual pictogram, 82-96%, 88-94%; models/questionnaires, 59-87%, 62-86%, and complaint of HMB, 74, 74%. The power of methods to identify HMB was also assessed using other analyses such as comparison of average measurements: statistical significance was reported for the PBAC, MFL, subjective complaint, and six questionnaires. In addition, PBAC scores, menstrual pictogram volumes, MFL, pad/tampon count, iron loss, and output from three questionnaires correlated significantly with values from a reference method in at least one study. In general, pictorial methods have been more comprehensively validated than questionnaires and models.
CONCLUSIONS
Every method to assess MBL has limitations. Pictorial methods strike a good balance between ease of use and validated accuracy of MBL determination, and could complement assessment of HMB using quality of life (QoL) in the clinical and research setting.
TRIAL REGISTRATION
PRISMA registration number: CRD42016032956 .
Topics: Adult; Diagnostic Techniques, Obstetrical and Gynecological; Female; Hemin; Humans; Menorrhagia; Middle Aged; Sensitivity and Specificity; Surveys and Questionnaires
PubMed: 30134884
DOI: 10.1186/s12905-018-0627-8 -
Frontiers in Global Women's Health 2021Women may be particularly vulnerable to alcohol harm, but many current theories fail to acknowledge the unique factors that influence female alcohol use. The biological...
Women may be particularly vulnerable to alcohol harm, but many current theories fail to acknowledge the unique factors that influence female alcohol use. The biological mechanisms underlying female alcohol consumption have largely been unexplored, although recently the menstrual cycle has been highlighted as a potentially important factor. This systematic review, using a narrative synthesis, examined the association between the menstrual cycle phases on alcohol consumption and aimed to determine whether hormonal contraception influences this association. The review follows PRISMA and SWiM guidelines, registration number: CRD42018112744. Electronic searches were conducted in the relevant databases with keyword (e.g., "menstrua"; "alcohol"). Thousand six hundred and sixty-two titles were identified, 16 of which were included in the review. Results were inconsistent regarding whether an association between menstrual cycle phase and alcohol consumption was found. Furthermore, there was inconsistency regarding which phase was associated with higher consumption, and different factors were reported to have moderated the direction, e.g., family history of alcohol use disorder (AUD), premenstrual syndrome (PMS). These conflicting results may be partly explained by variability in both study quality and design, and differences in measurement of cycle phase and alcohol consumption. More robust research is needed before conclusions can be drawn with regard to the role of the menstrual cycle and hormonal contraception on female drinking behavior. This review provides recommendations to strengthen research in this area.
PubMed: 34816249
DOI: 10.3389/fgwh.2021.745263 -
Health Science Reports Nov 2022The menstrual cycle in women is the main indicator of their reproductive health which is affected by the ongoing coronavirus disease 2019 (COVID-19) pandemic. This...
BACKGROUND
The menstrual cycle in women is the main indicator of their reproductive health which is affected by the ongoing coronavirus disease 2019 (COVID-19) pandemic. This review aims to summarize the effects of the COVID-19 infection and the global pandemic on the menstrual health of women.
METHODS
The literature search was conducted in PubMed, Cochrane library, and Google Scholar using keywords "COVID-19," "Menstrual Cycle," "Menstrual Cycle Irregularities," "Amenorrhea," "Polymenorrhea," and "Dysmenorrhea." The articles were selected according to the following inclusion criteria: (i) cross-sectional studies, (ii) cohort studies, (iii) surveys, and (iv) other observational studies observing the effects of SARS-CoV-2 infection or COVID-19 pandemic on menstrual health of women. Exclusion criteria included: case reports, gray literature, and website articles regarding menstrual health.
RESULTS
A total of 30,510 articles were shortlisted after a comprehensive search. Sixteen articles were included out of which 13 studies investigated the effects of the COVID-19 pandemic on the menstrual cycle while 3 evaluated the possible effects of COVID-19 infection on the menstrual health of women. Menstrual disorders or irregularities were a more common finding during the pandemic as compared to before ( = 0.008). Women affected by pandemic-related stress were more prone to changes in the duration of their menses ( = 0.0008), reported heavier bleeding ( = 0.028), and increased incidence of painful periods ( < 0.0001). COVID-19 infected women also reported changes in their menstrual cycle including irregular menstruation, increased symptoms of premenstrual syndrome, and infrequent menstruation.
CONCLUSIONS
Women suffering from COVID-19 infection or pandemic-associated stress and anxiety were more likely to experience irregular menstruation, dysmenorrhea, amenorrhea, and other menstrual abnormalities compared to those who were less exposed.
PubMed: 36248348
DOI: 10.1002/hsr2.881 -
Frontiers in Psychology 2018We systematically reviewed the literature to determine the influence of sex hormones on facial emotion processing (FEP) in healthy women at different phases of life....
We systematically reviewed the literature to determine the influence of sex hormones on facial emotion processing (FEP) in healthy women at different phases of life. Searches were performed in , and . Twenty-seven articles were included in the review and allocated into five different categories according to their objectives and sample characteristics (menstrual cycle, oral contraceptives, pregnancy/postpartum, testosterone, and progesterone). Despite the limited number of studies in some categories and the existence of inconsistencies in the results of interest, the findings of the review suggest that FEP may be enhanced during the follicular phase. Studies with women taking oral contraceptives showed reduced recognition accuracy and decreased responsiveness of different brain structures during FEP tasks. Studies with pregnant women and women in the postpartum showed that hormonal changes are associated with alterations in FEP and in brain functioning that could indicate the existence of a hypervigilant state in new and future mothers. Exogenous administration of testosterone enhanced the recognition of threatening facial expressions and the activation of brain structures involved in the processing of emotional stimuli. We conclude that sex hormones affect FEP in women, which may have an impact in adaptive processes of the species and in the onset of mood symptoms associated with the premenstrual syndrome.
PubMed: 29695991
DOI: 10.3389/fpsyg.2018.00529 -
BMC Complementary Medicine and Therapies Feb 2024Evening primrose oil (EPO), extracted from the seeds of Oenothera biennis, has gained attention for its therapeutic effects in various inflammatory conditions.
BACKGROUND
Evening primrose oil (EPO), extracted from the seeds of Oenothera biennis, has gained attention for its therapeutic effects in various inflammatory conditions.
METHOD
We performed a systematic search in multiple databases and defined the inclusion criteria based on the following PICOs: P: Patients with a form of inflammatory condition, I: EPO, C: Placebo or other therapeutic interventions, O: changes in inflammatory markers or patients' symptoms; S: randomized controlled trials. The quality of the RCTs was evaluated using Cochrane's RoB tool.
RESULTS
Several conditions were investigated in the literature. In rheumatoid arthritis, mixed results were observed, with some studies reporting significant improvements in symptoms while others found no significant impact. EPO showed some results in diabetes mellitus, atopic eczema, menopausal hot flashes, and mastalgia. However, it did not demonstrate effectiveness in chronic hand dermatitis, tardive dyskinesia, psoriatic arthritis, cystic fibrosis, hepatitis B, premenstrual syndrome, contact lens-associated dry eyes, acne vulgaris, breast cyst, pre-eclampsia, psoriasis, or primary Sjogren's syndrome. Some results were reported from multiple sclerosis after EPO consumption. Studies in healthy volunteers indicated no significant effect of EPO on epidermal atrophy, nevertheless, positive effects on the skin regarding hydration and barrier function were achieved.
CONCLUSION
Some evidence regarding the potential benefits of EPO in inflammatory disorders were reported however caution is due to the limitations of the current survey. Overall, contemporary literature is highly heterogeneous and fails to provide strong recommendations regarding the efficacy of EPO on inflammatory disorders. Further high-quality studies are necessitated to draw more definite conclusions and establish O. biennis oil effectiveness as an assuring treatment option in alleviating inflammatory conditions.
Topics: Pregnancy; Female; Humans; Oenothera biennis; gamma-Linolenic Acid; Linoleic Acids; Plant Oils
PubMed: 38360611
DOI: 10.1186/s12906-024-04378-5 -
BMC Women's Health Feb 2020Pictorial blood loss assessment charts (PBACs) represent the most widely used method to assess menstrual blood loss (MBL) in clinical trials. The aims of this review...
BACKGROUND
Pictorial blood loss assessment charts (PBACs) represent the most widely used method to assess menstrual blood loss (MBL) in clinical trials. The aims of this review were to: (1) determine the diagnostic accuracy of PBACs that have been validated against the reference alkaline hematin technique; (2) categorize the pitfalls of using obsolete and nonvalidated charts; (3) provide guidelines for development of a new PBAC or use of an existing chart to measure MBL in clinical trials; and (4) consider the feasibility of using pictorial charts in primary care.
METHODS
A literature review was conducted using Embase and MEDLINE databases. The review identified reports of women with self-perceived or actual heavy menstrual bleeding (HMB), bleeding disorders, abnormal uterine bleeding, leiomyomata (uterine fibroids) or endometriosis, and women undergoing treatment for HMB, as well as those with normal menstrual periods. Data were reviewed from studies that focused on the development and validation of PBACs and from those that used derivative noncertified charts to assess HMB.
RESULTS
Nine studies reported validation of PBAC scoring systems against the alkaline hematin technique. Across these studies, the sensitivity was 58-97%, the specificity was 7.5-95.5%, the positive and negative likelihood ratios were 1.1-13.8 and 0.14-0.56, respectively, and the diagnostic odds ratio was 2.6-52.4. The cut-off score above which the diagnosis of HMB was made ranged from 50 to 185. Several modifications of these PBACs were used in other studies; however, objective confirmation of their validity was not reported. Overall, there was widespread inconsistency of chart design, scoring systems, diagnostic cut-off limits and post-treatment outcome measures.
CONCLUSIONS
PBACs are best suited to the controlled and specific environment of clinical studies, where clinical outcome parameters are defined. The current lack of standardization precludes widespread use of the PBAC in primary care.
REVIEW REGISTRATION NUMBER
PROSPERO international prospective register of systematic reviews: CRD42016030083.
Topics: Adult; Clinical Trials as Topic; Diagnostic Techniques, Obstetrical and Gynecological; Female; Humans; Menorrhagia; Menstruation; Odds Ratio; Sensitivity and Specificity; Visual Analog Scale
PubMed: 32041594
DOI: 10.1186/s12905-020-0887-y -
Evidence-based Complementary and... Mar 2009The aim of this systematic review was to summarize randomized clinical trials (RCTs) assessing the effectiveness of acupuncture as published in Korean literature....
The aim of this systematic review was to summarize randomized clinical trials (RCTs) assessing the effectiveness of acupuncture as published in Korean literature. Systematic searches were conducted on eight Korean medical databases. Manual searches were also conducted through eight major Korean medical journals. The methodological quality was assessed using a Jadad score. Studies evaluating needle acupuncture or auricular acupuncture (AA) with or without electrical stimulation were considered if they were sham or placebo-controlled or controlled against a comparative intervention. We also excluded acupuncture as an adjuvant to other treatments and other forms of acupuncture were excluded. Seven hundred and nine possibly relevant studies were identified and 10 RCTs were included. The methodological quality of the trials was generally poor. Manual acupuncture was compared to placebo acupuncture in four studies of patients with chronic low back pain, shoulder pain, premenstrual syndrome and allergic rhinitis. Three studies tested AA (two trials) and electroacupuncture (one trial) against no treatment, while three trials compared acupuncture with other active therapeutic controls. The methodological limitations of the included trials make their contribution to the current clinical evidence of acupuncture somewhat limited. The trial for premenstrual syndrome, shoulder pain and chronic low back pain added a limited contribution among those included RCTs. However, well-designed RCTs of acupuncture with a rigorous methodology are in progress or have been completed in Korea and will contribute to establish or contribute to the current progress of research in this field.
PubMed: 18955298
DOI: 10.1093/ecam/nem130